Category: Covid-19 Vaccine

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Novavax Granted Authorization in United Kingdom for its COVID-19 Vaccine – Contagionlive.com

February 7, 2024

Last week, the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) announced it has granted marketing authorization for Novavaxs NVX-CoV2601 (Nuvaxovid) XBB15 COVID-19 vaccine for prevention of COVID-19 in individuals aged 12 years and older.1

Todays MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year, Novavax CEO John C. Jacobs, said in a statement last week. We are in ongoing conversations with additional UK partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one. We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the UK.1

According to the company, this authorization was based on non-clinical data showing the updated COVID-19 vaccine induced functional immune responses for XBB15, XBB116 and XBB23 variants. Additional non-clinical data demonstrated the vaccine induced neutralizing antibody responses to subvariants JN1which is the dominant strain in the United StatesBA286, EG51, FL151 and XBB1166 as well as CD4+ polyfunctional cellular (T-cell) responses against EG51 and XBB1166. These data indicate Novavaxs vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.1

Back in late November, the WHO granted Novavax an emergency use listing (EUL) for the same vaccine. The EUL was also based on non-clinical data.2

Novavax's COVID-19 vaccine, NVX-CoV2601 (Nuvaxovid), is distinct from many other COVID-19 vaccines as it does not utilize the mRNA platform.

The vaccine incorporates a patented saponin-based Matrix-M adjuvant. The Matrix-M adjuvant enhances both the cellular and humoral arms of the immune system.

The NVX-CoV2601 vaccine has practical advantages in terms of storage and shelf life. It can be stored at temperatures between 2 to 8 degrees Celsius, making distribution and administration more straightforward.

The Vaccines Novelty

This vaccine does not use the m-RNA technology, but the companys patented saponin-based Matrix-M adjuvant platform. The vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage. And as previously mentioned, it has demonstrated efficacy against multiple variants. 2

Contagion spoke to Seth Toback, MD, senior vice president, Medical Affairs, Novavax, at last falls IDWeek about the novelty of the vaccine.

Our vaccine is a protein based vaccine; it's really unique in that it uses the entire full length spike protein. It takes that spike protein and arranges it as a three-dimensional shape, which puts it in a very similar shape to the natural wild type SARS-CoV-2, said Toback. "So when we make antibodies towards that vaccine, the antibodies are more accurately reflecting the wild type virus and gives us a neutralization response. We then take that fully-spiked protein and we add it to our novel adjuvant, which is called matrix Mit enhances both the cellular and humoral arms of the immune system.2

References

1. Novavaxs Updated COVID-19 Vaccine Authorized in the United Kingdom. Novavax press release. January 24, 2024. Accessed January 31, 2024. https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Authorized-in-the-United-Kingdom

2. Parkinson J. Novavaxs Updated COVID-19 Vaccine is Granted EUL by WHO. ContagionLive. December 2, 2023. Accessed January 31, 2024 Novavaxs Updated COVID-19 Vaccine is Granted EUL by WHO. https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Authorized-in-the-United-Kingdom

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Novavax Granted Authorization in United Kingdom for its COVID-19 Vaccine - Contagionlive.com

New Research Suggests COVID-19 Vaccination In Mothers Reduces Infant Mortality And Complications – Zenger.News

February 7, 2024

Newborn babies whose mothers are vaccinated against COVID-19 are less likely to die or suffer complications, according to new research.

The study involving almost 200,000 Scandinavian moms found that babies whose mothers were vaccinated fared better than those whose mothers were not.

The study, published in the journal JAMA, serves as proof that vaccines are not only safe for pregnant women but could even potentially offer some health benefits to their babies.

The results showed babies born by women who chose to be vaccinated were less likely to suffer serious complications including death.

However, the research team admitted they couldnt explain the benefits to the babies of vaccinated mothers and said its unlikely to be a direct result of vaccination.

The study used national registers in Norway and Sweden to observe 196,470 newborns across the two nations accounting for nearly all newborn babies of women who became pregnant after the vaccines became available.

The first baby was born in June 2021 and the last in January 2023.

All babies were followed up for at least one month or as long as they were admitted to a neonatal unit.

Nearly half (48 percent) of the mothers had been vaccinated with one or more doses of a vaccine against COVID-19.

The majority (80 percent) received the Pfizer/BioNtech vaccine whilst a fifth (20 percent) received the Moderna vaccine.

In addition to lower infant mortality, the researchers also found a lower risk of two other serious complications in infants born to mothers who had been vaccinated.

Looking at a total of 15 neonatal complications after birth, the researchers found there was a rate of 0.9 infant deaths per 1,000 births in vaccinated mothers, whereas this rate was 1.8 per 100,000 in unvaccinated mothers.

Babies who suffered bleeds to the brain were also more prevalent in unvaccinated mothers at 3.2 per 1,000 compared with 1.7 per 1,000 in vaccinated mothers.

Those who suffered brain hypoxia/ischemia a type of brain damage caused by a lack of oxygen to the brain before or shortly after birth were also more likely to come from unvaccinated mothers (2.7 in 1,000 births vs 1.8 in 1,000 births of vaccinated mothers).

Mikael Norman, a professor of pediatrics and neonatology at the Department of Clinical Science, Intervention and Technology at the Karolinska Institutet in Sweden and first author of the study, explained that there was no explanation as to why babies from vaccinated mothers fared better than those from unvaccinated mothers.

We made several attempts to explain this finding, Dr Norman explained. A direct vaccine effect is unlikely.

Previous studies have shown that the vaccine does not cross the placenta and that it cannot be found in umbilical cord blood.

The researchers instead adjusted for several background factors that were unevenly distributed in the two groups of women and conducted seven different subgroup analyses of women and newborns.

No matter how we look at it, the finding remains and, therefore, we cannot say what the lower risk of death among infants of vaccinated women relates to, Dr Norman said.

We saw lower rates of cerebral hemorrhages and hypoxia-ischemic conditions of the brain in the newborns of vaccinated than in babies of unvaccinated in pregnancy.

The incidence of other bleedings, blood clots or inflammation in various organ systems did not differ between the groups.

Although the pandemic is over, Dr. Norman emphasized that the results of the study are of great importance for healthcare professionals offering counseling, authorities issuing recommendations and, above all, for anyone who will become pregnant in the future.

COVID-19 is still present in society and is probably something we will have to deal with for a long time, he said.

It is therefore very important for the one hundred thousand women who become pregnant every year in Sweden, and the 130 million in the world, to know that vaccination with mRNA-vaccines against COVID-19 is safe for their babies.

We found no increased risks. If anything, infants to vaccinated women had lower risks for some severe outcomes.

Produced in association with SWNS Talker

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New Research Suggests COVID-19 Vaccination In Mothers Reduces Infant Mortality And Complications - Zenger.News

Studies find that people living with HIV have been less vaccinated with the full initial regimen against COVID-19 – Medical Xpress

February 5, 2024

This article has been reviewed according to ScienceX's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility:

by Germans Trias i Pujol Research Institute

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In December, the journal Vaccines published an analysis of COVID-19 vaccination coverage among people with HIV in Catalonia between December 2020 and July 2022. The study led by the Center for Epidemiological Studies on HIV/AIDS and STI of Catalonia (CEEISCAT), a group from the Germans Trias i Pujol Research Institute (IGTP), in collaboration with researchers from the PISCIS Cohort group, evaluated the primary, monovalent, and booster doses.

The research aims to develop concrete action plans tailored to specific profiles to facilitate and promote vaccination. The study included a sample of over 200,000 individuals, 18,330 of whom have HIV and were vaccinated against COVID-19.

The researchers observed a lower rate of complete primary vaccination schedule in people living with HIV (78.2%) compared to those without this condition (81.8%), with the difference being more pronounced among migrant populations. However, people living with HIV received more booster doses than the rest.

The authors identified several factors that may contribute to the lower complete vaccination rates: having a previous diagnosis of SARS-CoV-2, the status of HIV infection, being a migrant, or having a complicated socioeconomic situation. These factors reflect barriers to vaccine access and health care.

The analysis has helped identify patterns and contexts that encourage vaccination against SARS-CoV-2 among people living with HIV, as well as determining the need to improve vaccine access and address the hesitancy of vulnerable populations in taking the doses, highlighting their efficacy and safety.

The same group of researchers has published another article in the Open Forum Infectious Diseases journal, this time focusing on migrant individuals with HIV. The findings indicate that these individuals (over 3,000 in the sample) have undergone fewer SARS-CoV-2 tests, yet they have a similar cumulative diagnosis rate as local natives.

Their vaccination rate, both in terms of the complete schedule and booster doses, is lower compared to those born in Catalonia. In contrast, there were more hospitalizations and admissions to the Intensive Care Unit (ICU) among migrants, even with similar durations of stays and mortality rates. Moreover, having two or more comorbidities in migrant individuals has been associated as a risk factor for severe COVID-19.

The study suggests possible impediments that could justify these results, such as economic inequalities, lack of information, structural discrimination, language barriers, or distrust in the health care system. With this data, strategies are expected to be developed to reach the migrant population and promote vaccination, as it is crucial for protecting the individual and curbing future epidemics at a social level.

More information: Daniel Kwakye Nomah et al, Comparative Analysis of Primary and Monovalent Booster SARS-CoV-2 Vaccination Coverage in Adults with and without HIV in Catalonia, Spain, Vaccines (2023). DOI: 10.3390/vaccines12010044

Daniel K Nomah et al, Disparities in Coronavirus Disease 2019 Clinical Outcomes and Vaccination Coverage Among Migrants With Human Immunodeficiency Virus in the PISCIS Cohort: A Population-Based Propensity ScoreMatched Analysis, Open Forum Infectious Diseases (2024). DOI: 10.1093/ofid/ofad693

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Studies find that people living with HIV have been less vaccinated with the full initial regimen against COVID-19 - Medical Xpress

Incorrect claim that COVID-19 vaccines caused a 143,233% surge in cancer results from flawed calculations that … – Health Feedback

February 5, 2024

CLAIM

Official CDC data: 143,233% surge in fatal cancers among Vaxxed Americans

DETAILS

Inadequate support: No reliable scientific study shows an association between COVID-19 vaccines and cancer. VAERS reports record any adverse events occurring following vaccination, regardless of whether the vaccine caused the event. Therefore, cancer-related reports to VAERS alone cant demonstrate that COVID-19 vaccines cause cancer. Misleading: Reporting requirements for COVID-19 vaccines are more stringent than for earlier vaccines, so simply comparing the number of reports for COVID-19 vaccines and flu vaccines can lead to erroneous conclusions.

KEY TAKE AWAY

Safety data and multiple studies show that COVID-19 vaccines effectively reduce the risk of severe or fatal COVID-19 cases, while the risk of serious side effects from vaccination is very small. But COVID-19 vaccines come with tighter reporting requirements than earlier vaccines, which results in more adverse event reports to vaccine safety databases compared to other vaccines. This doesn't indicate any safety issues but instead reflects an increased reporting rate.

The figure most likely originated from an article published on The Expos on 8 December 2023 titled, U.S. Government Data Reveals a Staggering 143,233% Surge in Fatal Cancer Cases. The article explicitly attributed this increase to the experimental Covid-19 injections.

The Expos is an outlet created in the first year of the COVID-19 pandemic that has since published misinformation and conspiracy theories, often based on distorted or misinterpreted data. The article discussed here is another example of such.

Contrary to what the headline and the Instagram post might suggest, the 143,233% figure doesnt come from an official report from the CDC or other public health agency. Instead, it was calculated by The Expos based on data from the U.S. Vaccine Adverse Event Reporting System (VAERS).

In this review, we will show that these calculations are incorrect and misleading in multiple ways and dont support the claim that COVID-19 vaccines cause or increase the risk of cancer. This claim is also inconsistent with published studies showing that people who received a COVID-19 vaccine arent more likely to develop cancer compared to unvaccinated people.

The Expos based its calculations on the number of cancer-related adverse events reported to VAERS after COVID-19 vaccination and after vaccination with the flu vaccines. Between December 2020 and August 2022, VAERS registered a total of 2,579 cancer-related adverse events following COVID-19 vaccination. The number of reports for flu vaccines was 64 between 2008 and 2020.

The article didnt specify whether the search for cancer-related adverse events included all events or only fatal, life-threatening and/or serious adverse events.

Considering the total number of COVID-19 and flu vaccine doses administered in the U.S. during those periods, The Expos calculated the rate of cancer-related reports per 100,000 doses administered. The result was 0.43 for COVID-19 vaccines (2,579 reports x 100,000 divided by 606 million doses administered) and 0.0003 for flu vaccines (64 reports x 100,000 divided by 1,720,400,000 doses administered).

The article claimed that the higher reporting rate following COVID-19 vaccination compared to flu vaccination was evidence that COVID-19 vaccines caused cancer, whereas flu vaccines didnt. Specifically, the article calculated that COVID-19 vaccination was 1,433 times (0.43/0.0003) or 143,233% (0.0003100/0.43) more likely to cause cancer than flu vaccination. But this isnt true.

The first hint that these figures are unreliable lies in the fact that The Expos made a mathematical error in calculating the rate of cancer reports per 100,000 flu vaccine doses. The result should be 0.003, not 0.0003 as the article claimed. This means that the alleged increase in cancer reporting is actually ten times lower than claimed: 143 times (or 14,323%) instead of 1,433 times (or 143,233%).

And the second and most important is that VAERS reports alone are inadequate to establish associations between a vaccine (in this case, the COVID-19 vaccine) and a health problem (in this case, cancer), although they can provide useful signals for further investigation that may establish a causal association. Therefore, the entire reasoning behind the calculations is flawed and doesnt support the claim.

VAERS is a national vaccine surveillance system co-managed by the U.S. CDC and the Food and Drug Administration. VAERS collects reports on any adverse events that occurred following vaccination, regardless of what caused them. This system is useful for rapidly detecting unusual patterns of adverse events that might be early signs of a safety problem with a vaccine. However, VAERS reports alone cant determine whether a vaccine caused an adverse event.

Furthermore, anyone can submit a report to VAERS, which means the database may also contain information that is incomplete, inaccurate, coincidental, or unverifiable.

A disclaimer on the site notifies users about these limitations, clearly stating:

The number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event, or as evidence about the existence, severity, frequency, or rates of problems associated with vaccines.

In brief, The Exposs calculations are based on a misuse of VAERS reports, and therefore dont provide any reliable evidence of a link between COVID-19 vaccines and cancer.

COVID-19 vaccines require stricter VAERS reporting compared to earlier vaccines, as Health Feedback explained in multiple reviews. Simply comparing the number of VAERS reports for different vaccines doesnt take into account these differences and can therefore be highly misleading.

In the case of COVID-19 vaccines, healthcare providers are required by law to report all serious adverse events that occur following vaccination regardless of causality. These include death, life-threatening adverse events, hospitalization, congenital anomalies, heart inflammation, multisystem inflammatory syndrome, serious COVID-19 cases, and any other important medical event that may require medical or surgical intervention. Cancer-related events likely fall within these categories.

In contrast, for flu vaccines healthcare providers are only required to report certain adverse events. These include anaphylaxis, shoulder injury related to vaccine administration, vasovagal syncope, Guillain-Barr Syndrome, and events described as contraindications in the manufacturers package insert. In general, only those serious adverse events, including deaths, that are linked to known side effects of the vaccine require reporting. It is doubtful that any flu vaccine lists cancer as a side effect.

In other words, while cancer and cancer-related adverse events that occur after COVID-19 vaccination must be reported to VAERS, reporting these events after flu vaccination is voluntary. Therefore, the higher rate of cancer-related reports following COVID-19 vaccination compared to flu vaccination most likely reflects differences in reporting rather than an actual increase in cancer rates among people who received a COVID-19 vaccine.

Determining whether a vaccine is causally associated with an adverse event requires an investigation that goes far beyond the number of VAERS reports. One critical step is to assess whether the vaccine is a plausible cause for the observed event. This isnt the case with COVID-19 vaccines and cancer.

As we explained above, The Expos didnt clarify whether the VAERS search for cancer-related adverse events involved new diagnoses, deaths, or other types of adverse events. Yet, the headline mentioned fatal cancers, conveying the message that at least some of these events were indeed fatal. However, this message is at odds with available scientific evidence.

The 2024 report by the American Cancer Society on cancer trends shows that, while some common cancers have been on the rise for the last three decades, the risk of dying from cancer has actually declined. This trend continued through 2021[1], which is inconsistent with COVID-19 vaccines leading to cancer deaths.

Published studies also show that people vaccinated against COVID-19 arent more likely to die from any cause compared to unvaccinated people[2,3].

After being extensively studied, no reliable evidence suggests that COVID-19 vaccines cause or increase cancer risk. Claims stating otherwise are usually founded on misinterpreted data and have no basis in fact.

The American Cancer Society and the U.S. National Cancer Institute state that no evidence suggests that COVID-19 vaccines cause or make the cancer grow or recur. In fact, cancer patients are at a high risk for severe complications from COVID-19. Therefore, both institutions recommend that people with cancer and cancer survivors, as well as caregivers and close contacts, get the COVID-19 vaccine.

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Incorrect claim that COVID-19 vaccines caused a 143,233% surge in cancer results from flawed calculations that ... - Health Feedback

Latest COVID-19 Vaccine Offers 54% Increased Protection, CDC Reports – Medriva

February 5, 2024

In a recent development, the latest COVID-19 vaccine is found to offer significantly higher protection against the symptoms of the virus compared to those who are unvaccinated. According to the Centers for Disease Control and Prevention (CDC), the vaccine provides an increased protection of 54% against the virus, a promising development in the fight against the pandemic.

According to the CDCs updated information, the 2023-2024 COVID-19 vaccine shows enhanced protection against the variants responsible for most infections and hospitalizations in the United States. The vaccine has shown to be effective against many variants of the virus, reducing the likelihood of getting COVID-19 by 54%. The CDC recommends everyone aged six months or older to get the updated COVID-19 vaccine, especially those at higher risk of severe illness from respiratory diseases.

The latest COVID-19 vaccines offer robust protection against symptomatic infection, including from the JN.1 variant, as shown by early CDC data. The vaccines provided a significant 54% protection against symptomatic infection among immunocompetent adults who were recently vaccinated. The US COVID-19 vaccination program aims to prevent severe disease, and tracking vaccine effectiveness against symptomatic infection provides an early look at how well the vaccines are working.

Data suggests that COVID-19 continues to circulate at high levels in the US, with tens of thousands of hospitalizations and hundreds of deaths each week. Unfortunately, only about 1 in 5 adults and 1 in 9 children have received the latest COVID-19 vaccine, compared to nearly half who have received the flu vaccine this season.

The updated 2023-2024 monovalent XBB 1.5 COVID-19 vaccine has shown increased protection against symptomatic SARS-CoV-2 infection, particularly in relation to the co-circulating Omicron variants. The vaccine provided approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared to those who did not receive the updated vaccine. Vaccination provides protection against JN.1 and other circulating lineages. The CDC recommends all persons aged six months and older should receive the updated COVID-19 vaccine.

Despite the promising effectiveness of the updated vaccine, the vaccination coverage in the U.S. remains low. According to the latest data from the CDC, only 22% of U.S. adults and 11% children have received the new shots. The CDC urges everyone over six months to get the new shots for protection against COVID and evolving variants. Experts emphasize that vaccine effectiveness is known to wane over time, but getting the vaccine remains crucial even if cases are declining in a community.

In conclusion, the latest COVID-19 vaccine offers a compelling defense against the virus, particularly regarding symptomatic infections. As the virus continues to evolve, it is vital to stay updated with your vaccination status and adhere to CDC guidelines for maximum protection.

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Latest COVID-19 Vaccine Offers 54% Increased Protection, CDC Reports - Medriva

More good news on the real-world effectiveness of the updated COVID-19 vaccine! – Those Nerdy Girls

February 5, 2024

February 2, 2024

More good news on the real-world effectiveness of the updated COVID-19 vaccine! A recent analysis by the CDC found that people who received the updated COVID vaccine were less than half as likely to have a symptomatic COVID infection over the next four months, including the time period of the new JN.1 variant.

Like all observational studies, these data have some potential biases that could both under or overestimate the vaccine effectiveness. But combined with other recent data showing good protection against hospitalization for those who had the updated vaccine, the evidence for the value of getting the updated vaccine is mounting.

And obviously, Taylor and Travis know the benefit of vaccines All too well .

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More good news on the real-world effectiveness of the updated COVID-19 vaccine! - Those Nerdy Girls

Malawi Launches New COVID-19 Vaccination Campaign Amid Rising Cases – Voice of America – VOA News

January 30, 2024

Blantyre, Malawi

The Malawi government and the World Health Organization launched a new COVID-19 vaccination campaign on Monday in 10 of the countrys 29 districts. This is partly in response to new cases confirmed in the past three weeks in several districts across the country.

Nsanje District in southern Malawi currently leads in the number of COVID-19 cases recorded this year.

George Mbotwa, spokesperson for the district health office, said the district has registered 17 new cases in the past three weeks and some are health workers.

Initially there were two, but we had up to eight cases that were health workers, he said. Some of them have now been confirmed as negative, and others are being followed up to ensure that they are fully recovered before they can resume work.

By Monday, Malawi cumulatively recorded 89,202 confirmed COVID-19 cases, including 2,686 deaths, since the first cases were confirmed in the country in April 2020.

Malawis Ministry of Health says the new vaccination campaign will help boost the number of people getting the COVID-19 vaccine. Vaccination rates in some areas of Malawi are as low as 40%.

It also says the WHO-funded campaign would help avoid waste of the vaccine as was the case in 2020 when the government destroyed nearly 20,000 expired AstraZeneca doses.

Many of those doses expired due to vaccine hesitancy amid concerns of its safety and efficacy.

However, recent government public health campaigns on the importance of COVID-19 shots have helped defeat that hesitancy.

Mary Chawinga, a mother of two of Machinjiri Township in Blantyre, said she has had the vaccine and is awaiting a booster.

And I am ready to take my children, because prevention is better than [a] cure they say, Chawinga said. You never know how the wave will be like this time around considering the way it was way back in 2020. We have had it in 2021, and now this is 2024.

Another mother of two, Habeeba Nyasulu, said she received the COVID-19 doses during the first campaign and encourages others to get the shot.

I know that we are not safe until everyone is safe, she said. So, let others also receive the vaccine. I know that the vaccine does not prevent us from getting infected, but it helps us when we contract it not to be critically ill.

Maziko Matemba is a community health care ambassador in Malawi, said the COVID-19 threat is still present in the country.

Malawi didnt vaccinate a required number of people against COVID-19, because the targeted population was about 11 million Malawians, Matemba said. But we were less than half about 2 or 3 million Malawians who were able to get vaccinated.

Matemba said the country now needs to have the vaccine in the right places and encourage more people to get vaccinated.

The Ministry of Health says the new campaign targets 10 of the countrys 29 health districts that have recently recorded new cases. These include Machinga, Blantyre, Dowa, Mzimba and Nsanje districts.

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Malawi Launches New COVID-19 Vaccination Campaign Amid Rising Cases - Voice of America - VOA News

Breast milk may have potential protective effects against SARS-CoV-2, say researchers – Medical Xpress

January 30, 2024

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The COVID-19 pandemic was an especially harrowing time for pregnant people and new parents.

The uncertainties about how the new coronavirus could affect a pregnant person and their developing fetusnot to mention being cut off from support networksleft many expecting parents feeling isolated and anxious.

"It was a very surreal time," says Jenny Doyle, a Toronto mom who gave birth to her first child, Elliott, in 2020 and spent hours researching how the first vaccines made available the following year might affect her and her child. "At the time, vaccines for infants were still so far away. I remember hoping that some of the protection I'd received from my vaccine would pass through to Elliott."

Now, new findings from a study led by researchers at the University of Toronto and its partner hospitals suggest that is the case.

Published in the American Journal of Clinical Nutrition, the study looked for antibodies against SARS-CoV-2 in breast milk from three different cohorts: individuals who contracted COVID-19 while pregnant or nursing, routine milk bank donors and individuals who received two doses of the COVID-19 vaccine while pregnant or nursing.

The researchers detected antibodies in breast milk from roughly half of the people in the COVID-19 positive cohort. That's compared to less than 5 percent of routine milk bank donors, who did not have any known exposures to COVID-19. In the vaccinated cohort, they found that antibodies levels were higher in people who had received the Moderna vaccine compared to those who had received the Pfizer-BioNTech vaccine. Unexpectedly, people who had shorter intervals between their first and second doses had higher antibody levels than those who waited longer between their immunizations.

"That finding definitely surprised me," says Samantha Ismail, the study's first author who completed her master's degree in the lab of Deborah O'Connor, the Earle W. McHenry Professor and chair of Temerty Medicine's department of nutritional sciences. "In [blood] serum, it's the other way around where longer intervals between doses typically result in higher antibody levels, suggesting that something different is happening in this lactating population."

In addition to Ismail and O'Connor, the study was led by Sharon Unger, medical director of the Roger Hixon Ontario Human Milk Bank at Sinai Health and a U of T professor of medicine and nutritional sciences, and Susan Poutanen, microbiologist and infectious disease consultant and Sinai Health and U of T associate professor of laboratory medicine and pathobiology.

The team took the study one step further by showing that some breast milk samples could prevent SARS-CoV-2 from infecting cells in a lab setting. Within the COVID-19 positive cohort, milk that contained antibodies against the virus were more likely to be neutralizing and immunization with the Moderna vaccine was associated with a stronger neutralizing capacity than the Pfizer-BioNTech vaccine.

The researchers also found a small but significant number of breast milk samples that prevented SARS-CoV-2 infection despite having undetectable levels of antibodies, suggesting that there could be other components in human milk that are active against SARS-CoV-2.

While these findings provide strong evidence to support the potential protective effects of human milk, Ismail cautions that the study alone is not enough to prove that breast milk provides tangible protection against COVID-19.

"COVID-19 vaccination and infection result in antibodies in human milk that have neutralizing capacity, but we don't know for sure how the neutralizing capacity seen in the lab translates to protection in infants," says Ismail, who is now a second-year medical student at U of T.

She points out that previous studies have shown a clear protective effect of antibodies in human milk against other viruses like enterovirus and rotavirus. To date, such studies have not been done with COVID-19.

Even so, the findings provide reassuring news to parents like Doyle, who breastfed her son longer than she had intended to ensure that he was still getting breast milk when she received her second COVID-19 vaccine.

"Trying to figure out how to protect this tiny being in that scary and bleak time, I was grasping at every little piece of information and whatever little piece of hope we had."

More information: Samantha Ismail et al, SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies, The American Journal of Clinical Nutrition (2023). DOI: 10.1016/j.ajcnut.2023.10.008

Journal information: American Journal of Clinical Nutrition

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Breast milk may have potential protective effects against SARS-CoV-2, say researchers - Medical Xpress

In Utero COVID-19 Exposure Associated With Respiratory Distress Among Infants – Drug Topics

January 30, 2024

A new study found the risk of developing respiratory distress (RD) among SARS-CoV-2 exposed uninfected (SEU) full-term neonates to be uniquely high. However, the study also found that maternal vaccination reduced the incidence of the condition. Findings from the UCLA-led study were published in Nature Communications.1

Although prior research has examined links between RD and SEU neonates, the associations have often been attributed to well-studied risk factors like maternal hypoxia and multiorgan failure that cause premature delivery. Addressing a gap in the relevant literature, investigators noted that these previously cited factors do not apply to cases of RD among infants born at full term.

Using information about the clinical features of RD in SEU infants, the effect of maternal vaccination on infant RD, and proteomic measures to identify unique proteins expressed in SEU infants, investigators explored the impact of in utero COVID-19 exposure on the development of RD among full-term neonates.

We found unusually high rates of respiratory distress shortly after birth in the full-term babies born to mothers who had COVID-19 during pregnancy, said Karin Nielsen, MD, senior study author and professor of pediatrics in the division of pediatric infectious diseases at the David Geffen School of Medicine at UCLA in a press release.2 The mothers had not been vaccinated prior to acquiring COVID, indicating that vaccination protects against this complication.

In total, 221 pregnant persons with COVID-19 and 199 COVID-19 exposed infants were included for analysis in the longitudinal cohort study conducted between April 2020 and August 2022. Among 151 (68%) mothers that were unvaccinated, 16% (23) experienced severe or critical disease, whereas only 4% (3) of vaccinated mothers experienced severe or critical disease, demonstrating the protection that vaccination grants against disease severity.

Although none of the infants tested positive for SARS-CoV-2 at birth, 17% (34) were diagnosed with RD. Maternal vaccination before COVID-19 infection was associated with a significantly lower rate of respiratory distress in infants; among the 34 infants born with RD, only 15% (5) were born to vaccinated mothers (P = .012). In contrast, 41% (63) of infants without RD were born to vaccinated mothers.

Study results also demonstrated that the prevalence of severe or critical COVID-19 in mothers was significantly higher among infants with RD (21%) compared to those without RD (6%) (P = .009). Investigators noted that when pregnant patients received at least 1 mRNA vaccine dose prior to SARS-CoV-2 infection, the odds of developing RD among neonates decreased by 67% (OR: 0.33, 95% CI: 0.100.96).

Proteomic evaluation found that exposure to SARS-CoV-2 activated an inflammatory cascade that dysregulated the ciliary function pathway and amplified immunoglobulin E production among neonates.1

Whereas prior research has studied the link between premature infants and RD, current results offer insight into how the condition presents at a later gestational age.

Not only do our results show higher rates of respiratory distress in SARS-CoV-2 exposed uninfected infants when compared to the general population, but we observed more cases of respiratory distress at later gestational ages than anticipated, when neonates should presumably have more mature lung anatomy, said investigators.

In light of study findings demonstrating the benefit of COVID-19 vaccination on the health of both mother and infant, investigators emphasized the importance of public health interventions as they contribute to improved well-being among the parties.

Our findings can help inform the mechanisms by which maternal SARS-CoV-2 infection during pregnancy may impact fetal development and neonatal outcomes, investigators wrote. Moreover, our study highlights the importance of public health interventions and vaccination efforts that target pregnant individuals due to the potential for lasting effects on the health of both the mother and the infant.

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In Utero COVID-19 Exposure Associated With Respiratory Distress Among Infants - Drug Topics

Viral Posts Misuse Rat Study to Make Unfounded Claims About COVID-19 Vaccines and Autism – FactCheck.org

January 27, 2024

SciCheck Digest

COVID-19 vaccination during pregnancy benefits both mother and baby. Side effects are generally mild, and studies dont show negative effects on the baby. A criticized study that gave COVID-19 vaccines to pregnant rats doesnt show that vaccines cause autism or that people shouldnt get COVID-19 vaccines, contrary to claims.

COVID-19 vaccinationprotectspregnant people from severe COVID-19 and reduces COVID-19 risks for babies. As is the case in people who arent pregnant, side effects inpregnant peopleare usually mild and resolve within days. Studiesdo not showa link between COVID-19 vaccination and negative pregnancy outcomes or health problems for babies.

Long-standing claims that childhood vaccines cause autism have beenroundlydebunked. Long-term studies provide reassurance that vaccination during pregnancy againstfluandotherdiseases does not increase a childs risk of autism, a developmental disorder. And a recentstudydid not find a connection between maternal COVID-19 vaccination and increased risk of developmental delay at 18 months of age.

However, social media posts have misused findings from a recentstudyof COVID-19-vaccinated pregnant rats and their pups toback upunfounded claims that people should not take COVID-19 vaccines, or to promote unsubstantiated claims about vaccines and autism.

Im forever grateful I risked my reputation in my personal life to warn people far and wide to NOT get this experimental $h0t! said one post sharing an article from the Epoch Times on the new study.

Commentator Candace Owens, who has a history of spreading misinformation, shared a post about the study on X, the platform formerly known as Twitter, saying it supported long-standing, debunked claims about vaccines and autism. Thats because vaccines and autism have always been linked, which affected mothers have been trying to tell the general public for decades, she said. Posts about the study have continued to spread.

Researchers who study brain development expressed concerns to us about how the rat study was designed and interpreted.

The authors of the study, published Jan. 10 in Neurochemical Research, did behavioral and other tests on rats born to 15 female rats impregnated by five males. The pregnant rats either received an adult human-sized dose of the Pfizer/BioNTech vaccine against COVID-19 or a saline injection.

The researchers wrote that they observed autism-like behaviors, such as decreased interactions with an unfamiliar rat, and decreased neurons in regions of the brain in male rats born to vaccinated mothers. They also said they found alterations in the level of a particular protein in the brains of rats of both sexes born to vaccinated mothers.

Even if the results are taken at face value, its not possible to conclude from a study in rats that vaccines cause autism, because rat and human biology and behavior are different. Researchers do study rats to better understand autism, but these studies are meant to generate hypotheses, not change medical care.

Experts also told us there were various factors that made the study hard to interpret, such as the high vaccine dose given to the pregnant rats, despite their small size, the lack of replication of the experiment and issues with the statistical analyses.

Caution should be exercised in generalizing these results to humans, the authors themselves wrote in the paper. Corresponding author Mumin Alper Erdogan, a professor in the department of physiology at Izmir Katip Celebi University in Turkey, did not respond to a request for comment from us. However, he did answer questions from Health Feedback, responding to some criticisms and clarifying that there was no intention, desire, or effort on our part to oppose vaccinations or make similar accusations.

Vaccines do not cause autism, a spokesperson from the Centers for Disease Control and Prevention told us in an email. To date, no vaccine safety monitoring data in the United States indicates a causal association between autism and COVID-19 vaccination.

Multiple scientists expressed concerns to us about the high COVID-19 vaccine dose given to the pregnant rats.

Staci Bilbo, a neuroimmunologist at Duke University who studies how the immune system influences brain development, told us that vaccine doses are extremely carefully adjusted during vaccine development. Researchers determine the smallest dose that will generate the needed immune response.

Giving the rats which on average weighed less than 8 ounces a full adult human COVID-19 vaccine dose was equivalent to giving an average-weight American woman around 350 times the recommended dose of the Pfizer/BioNTech vaccine, according to Bilbos calculation.

If you give a high enough dose of anything its going to probably have impacts, she said.

In response to questions about the dose, Erdogan told Health Feedback that theres no established standard for mRNA vaccine dosages in rats due to the lack of specific dose studiesand that relatively high doses have been used for studies of other animalsof varying sizes.

Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvanias Perelman School of Medicine, also told FactCheck.org that the high dose given to the rats was a limitation of the study. This does not make the results irrelevant, since super high dose can potentially detect some potential issue that might manifest in some humans, but if I were reviewing this article I would make the authors emphasize the multiple of how much larger the effective dose in the animal study is to the current human dose, and include the qualifier that this is one reason why it is not clear whether these results are relevant to what is experienced by humans given the current doses.

Christopher Coe, a psychoneuroimmunologist and professor emeritus at theUniversity of Wisconsin-Madison, told us via email that were it his study, he would also have wanted to give the rats a low dose of the vaccine to see if results varied by dose. Coe has done studies on the effects of infection and maternal inflammation on the fetus during pregnancy.

Coe said it was important to take reports of drug or vaccine adverse events seriously, but he also listed numerous other concerns about the paper.

For example, he said the researchers did not provide information about the rats and their pregnancies that could have shed light on how the injections affected them and whether or not this was likely to be relevant to humans. This missing information included, for instance, whether the rats had an inflammatory reaction to the injections the hypothesized pathway for how vaccination during pregnancy might affect neurodevelopment.

Teresa Reyes, a professor of pharmacology and systems physiology at the University of Cincinnati College of Medicine, told us via email that information was missing on the length of the rat pregnancies. If the pregnancy length was significantly different, it could indicate that the litters were born prematurely, which confounds the interpretation of the findings, she said.

In humans, COVID-19 vaccination during pregnancyhas not been shownto increase preterm birth and may even protect against it.

She also said that information was missing on the weights of the pregnant rats, or dams, over time and their pups. Significant differences in weight (e.g., vaccine exposed dams lost weight during the study) could indicate that the dams were severely ill in response to the vaccine, again confounding the interpretation of the study, she said.

Coe said that he would have wanted to replicate the findings rather than rush to publish on the basis of one experiment, suggesting that both the authors of the paper and outside researchers should try to replicate the results.

And he expressed concern about the studys statements that altered rat behaviors were autism-like, given that autism spectrum disorder is a complex neurodevelopmental disorder.

Brian Lee, anassociate professor of epidemiology and biostatistics at the Drexel University Dornsife School of Public Health who studies prenatal exposures and autism risk, told us via email that it is hard to diagnose autism in humans, let alone in rats. Its hard to read into some behavioral tests for a rat and imagine it translates 100% to an autism diagnosis in humans, he said.

There also appeared to be issues with the studys experimental design and statistical analysis.

For instance, studies of prenatal exposures need to account for something called litter effects or the fact that the multiple offspring born in the same litter to the same animal mother might share characteristics.

The authors did not describe any approach to address the potential for a litter confound which could skew the findings (e.g., one dam has a significantly different response, multiple pups are used from that litter, and this skews the findings), Reyes said.

Additionally, the authors wrote that they set out to determine whether maternal vaccination led to any sex-specific neurobehavioral changes or ways in which sex and vaccination, in combination, affected the rats behavior.

The authors didnt find evidence of such sex-specific effects on social behavior, but theynevertheless went on to compare social behavioral results from the male pups of vaccinated mothersversus unvaccinated mothersand highlighted the results something Reyes said they shouldnt have done. By improperly using statistics to analyze the data, the conclusions are not valid, she said. It is impossible to verify the stated claims because statistics were used incorrectly.

A persons likelihood of being autistic isinfluencedby a combination of genetics and other factors. These likely include older parental age and whether there are complications at a childs birth,includingextreme prematurity or very low birth weight. As weve writtenpreviously, many lines of evidence contradict the idea long spread by anti-vaccine groups that childhood vaccines cause autism.

Some theoretical concerns about vaccines given during pregnancy and autism are based on researchindicatingthat infections during pregnancy might slightly increase the risk of a child later developing autism.We know that immune activation can impact the way the brain develops, and sometimes thats in adverse ways and yet we also know that the immune system is important in just normal brain development, Bilbo said.

But Bilbo said the bodys immune system reacts differently to a serious infection than it does to vaccination.A vaccine against a virus is designed to expose the body to just enough viral material to teach the immune system to recognize the infectious agent, should it encounter it later. Dose matters, obviously, Bilbo said. It matters quite a bit.

Studies in humans provide reassurance of recommended vaccines benefits and safety.

The Tdap vaccine which protects against tetanus, diphtheria and pertussis, orwhooping cough isrecommendedduring pregnancy to protect newborns until they are able to be vaccinated against pertussis themselves at two months of age. The CDC began to recommend the vaccine routinely in all pregnancies in2012, based on an uptick in pertussis, which can lead to death in very young babies.

A 2018studyof children born in Kaiser Permanente Southern California hospitals between 2011 and 2014 found no increased risk of autism in those whose mothers had been vaccinated against Tdap during pregnancy.

Flu vaccines havelongbeenrecommendedfor pregnant people during flu season and reduce risks for both the mother and the baby. A 2020 Swedishstudylooking at vaccination against the 2009 pandemic swine flu found no link between vaccination during pregnancy and increased autism risk.

A 2017study, looking at children born in the Kaiser Permanente Northern California health system between 2000 and 2010, found no association overall between autism and flu vaccination during pregnancy. The researchers did find a suggestion of increased autism risk when mothers were vaccinated during the first trimester of pregnancy but said that statistical analyses indicated the finding could be due to chance.

In the case of COVID-19 vaccines, researchhas not indicatedany negative impacts on pregnancy outcomes or on babies of vaccinated mothers. In fact, theres some evidence maternal vaccination is protective against certain bad pregnancy outcomes, such as preterm birth and stillbirth.

Astudypublished on Jan. 22 in JAMA Pediatrics followed around 4,200 children born to mothers who enrolled in the study between May 2020 and August 2021. At 18 months, scores on a developmental screening test did not differ between children whose mothers got COVID-19 vaccines during pregnancy versus those whose mothers didnt.

The authors wrote that these data suggest that maternal vaccination against COVID-19 during pregnancy was safe from the perspective of offspring neurodevelopment through 18 months of age.

Its small and just 1 study, and of course more study is needed, but the findings are reassuring, said Drexels Lee, who was not involved in the new study.

Coe emphasized the benefits of COVID-19 vaccination during pregnancy. There are now many clinical studies that have demonstrated the benefits for safer pregnancy outcomes (as compared to the risk of an actual infection), as well as the reduced risk for young infants of getting a respiratory infection during the first 6 months of life, he said.

There is no known link between COVID-19 vaccines and the occurrence of autism spectrum disorder (ASD), a Pfizer spokesperson told us in an email. With hundreds of millions of doses of COVID-19 vaccines from BioNTech and Pfizer administered globally, the benefit-risk profile of our vaccines remains positive for all authorized indications/uses and age groups.

Editors note: SciChecks articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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Original post:

Viral Posts Misuse Rat Study to Make Unfounded Claims About COVID-19 Vaccines and Autism - FactCheck.org

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